Primary Aldosteronism LC-MS/MS-specific Cutoffs

Completed

• Conditions: Primary Aldosteronism
• Interventions: Diagnostic Test: Captopril Challenge Test

• Registration Number: NCT05959863
• Lead Sponsor: Chongqing Medical University

Brief Summary

Aims to evaluation the LC-MS/MS-specific cutoffs of PA screening and CCT test.

Detailed Description

Plasma aldosterone concentration and plasma renin activity / concentration measurement are important for early screening and diagnosis of Primary Aldosteronism (PA), most measurement methods are currently based on chemiluminescence, which may be cross-reactivity with other compounds and metabolites, leading to misdiagnosis or missed diagnosis of PA patients. Liquid chromatography tandem mass spectrometry (LC-MS/MS) has been introduced into the clinical routine analysis of steroid hormones due to its higher specificity and is increasingly used for the diagnosis of adrenal diseases. However, it is unknown for the cut-offs of PA screening and CCT test based on this technology in China. Therefore, the purpose of this study is to establish the screening and CCT cut-off point for primary aldosteronism based on LC-MS/MS technique at multicenter in China.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-07-25
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

1. Age is between 18-75 years old.
2. Hypertension patients with high risk factors for PA (meeting one of the following criteria): a.Persistent hypertension (> 150 / 100mmHg); b. Refractory hypertension (combined with 3 antihypertensive drugs and one used as a diuretic,Blood pressure is still greater than 140 / 90 mmHg or four antihypertensive drugs are needed to control blood pressure of less than 140 / 90 mmHg); c.Hypertension with adrenal accidental tumor; d.Hypertension is associated with hypokalaemia;
3. Recent and stable use of antihypertensive drugs for more than 2 weeks, The drug types may include: β receptor blockers, CCB(calcium channel blockers), angiotension converting enzyme inhibitors(ACEi), Angiotensin Receptor Blocker(ARB), mineralocorticoid receptor antagonists(MRA), and other diuretics.

Exclusion Criteria

1. Patients who are unwilling to participate and complete the study or refuse to sign a written informed consent for the study;
2. Patients diagnosed with other secondary hypertension (such as renal hypertension, renal artery stenosis, pheochromocytoma, Cushing's syndrome, etc.);
3. Combined with severe renal insufficiency eGFR <30 ml/min / 1.73 m2, Or patients with liver insufficiency OR liver failure (Alanine aminotransferase and / or aspartate aminotransferase increased 2.5 times above the upper limit of normal);
4. Clinical assessment of a dressing change risk, Including: Heart failure (NYHA stage grade II or above), any one or more of the stroke, myocardial infarction, and unstable angina pectoris diagnosed within three months;
5. Patients who are pregnant or who are currently being treated with sex hormones and glucocorticoids;
6. incurable malignancy;
7. Other reasons make it difficult to change or stop the drug to complete the diagnosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Aldosteronism Group	Captopril Challenge Test	Patients diagnosed with primary aldosteronism
Essential Hypertension Group	Captopril Challenge Test	Patients diagnosed with essential hypertension

Primary Outcome Measures

Name	Time	Method
Establish a LC-MS/MS assay-specific cut-off point of screening without medication interfering for primary aldosteronism.	At baseline without medication interfering.	Measure the plasma aldosterone concentration and plasma renin activity by LC-MS/MS.Plasma aldosterone concentration and plasma renin activity will be combined and reported as an aldosterone-to-renin ratio.
Establish a LC-MS/MS assay-specific cut-off point of CCT without medication interfering for primary aldosteronism.	2 hours after the captopril challenge test without medication interfering.	Measure the plasma aldosterone concentration by LC-MS/MS.

Secondary Outcome Measures

Name	Time	Method
Establish a LC-MS/MS assay-specific cut-off point of screening with medication interfering for primary aldosteronism.	At baseline with medication interfering.	Measure the plasma aldosterone concentration and plasma renin activity by LC-MS/MS.; Plasma aldosterone concentration and plasma renin activity will be combined and reported as an aldosterone-to-renin ratio.
compare the different criteria of Captopril Challenge Test for the diagnosis of primary aldosteronism.	2 hours after the captopril challenge test without medication interfering.	plasma aldosterone concentration were measured using automated chemiluminescence immunoassays.

Trial Locations

Locations (2)

Qifu Li; 🇨🇳 Chongqing, Chongqing, China

Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China